Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH… recallZ-1564-2013 · Medtronic Inc. Cardiac Rhythm Disease Management · initiated Jun 12, 2013
Class II Terminated All recalls posted in June 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Inc. Cardiac Rhythm Disease Management or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. The two affected catheter lots are mislabeled and do not accurately reflect the catheters contained within each package.
FDA root cause category: Labeling mix-ups
What the company is doing
Medtronic "Urgent Field Safety Notice" letter dated June 2013 to all affected customers. The letter described the affected product, problem and actions to be taken. The letter instructed customers to remove and quarantine all affected product within their inventory and return the affected product to Medtronic. For questions contact your local Medtronic representative.
Recall details
- Recall number
- Z-1564-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 12, 2013
- Posted by the FDA
- Jun 21, 2013
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Management
- Quantity
- 15
- Product code
- DQY
- FDA submissions
- K021256, K103386
- Distribution
- Internationally distributed: to countries of Germany and Poland.
Product description
Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F Product Usage: The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
Code information (models, lots, serial numbers)
Model # LA8EBU45SH, Lot # 0006722866 and Model # LA6IMAD, Lot # 0006724224.
Other devices under the same FDA submission
53 devices cleared under K021256, K103386 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Launcher LA6JR40Medtronic, Inc. · CATHETER, PERCUTANEOUS10 reports
- Launcher LA6IMAKMedtronic, Inc. · CATHETER, PERCUTANEOUS9 reports
- Launcher LA6EBU35Medtronic, Inc. · Catheter, percutaneous9 reports
- Launcher LA6EBU35Medtronic, Inc. · CATHETER, PERCUTANEOUS1 death5 reports
- LAUNCHER LA6EBU35Medtronic, Inc. · Catheter, percutaneous5 reports
- Launcher LA6JR35Medtronic, Inc. · CATHETER, PERCUTANEOUS4 reports
- Launcher LA6JL35Medtronic, Inc. · CATHETER, PERCUTANEOUS4 reports
- Launcher LA6AL75Medtronic, Inc. · CATHETER, PERCUTANEOUS4 reports
- Launcher LA6JL40Medtronic, Inc. · CATHETER, PERCUTANEOUS3 reports
- Launcher LA6AR10Medtronic, Inc. · CATHETER, PERCUTANEOUS3 reports
- Launcher LA5JR40Medtronic, Inc. · CATHETER, PERCUTANEOUS2 reports
- Launcher LA6JR35SHMedtronic, Inc. · CATHETER, PERCUTANEOUS2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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